OCT and Microperimetry in Patients With Active Neovascular ARMD (CORFI) (CORFI)
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|ClinicalTrials.gov Identifier: NCT03435926|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : January 23, 2019
ARMD is the main cause of visual disability after 50 years old in France. Patients with active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular OCT but also on angiography when necessary).
The aim of this study is to evaluate the link between active neovascularization found on OCT and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.
Quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up for each patient. The mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered.
In case no link will be found, for instance bad fixation quality without exudative signs on OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.
|Condition or disease|
|Choroidal Neovascularization, Visual Field, Visual Acuity|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF|
|Actual Study Start Date :||February 13, 2018|
|Estimated Primary Completion Date :||February 13, 2021|
|Estimated Study Completion Date :||February 13, 2021|
- fixation stability measured by microperimetry and exudative signs on OCT [ Time Frame: 2 years ]
quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up.
The fixation stability is classified as follows:
- Stable if more than 75% of the fixation points are contained inside the circle of 2 degrees of diameter
- Relatively unstable if more than 75% of the fixation points are contained within the circle of 4 degrees of diameter and less than 75% contained within that of 2 degrees of diameter
- Unstable if less than 75% of the fixation points are contained within the circle of 4 degrees of diameter
- Bivariate Contour Ellipse Area (BCEA) value [ Time Frame: 2 years ]BCEA will be gathered at each consultation over the two-years follow-up
- mean central retinal sensitivity [ Time Frame: 2 years ]mean central retinal sensitivity will be gathered at each consultation over the two-years follow-up
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 2 years ]BCVA will be gathered at each consultation over the two-years follow-up
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435926
|Contact: NATHALIE LABROUSSE, Drfirstname.lastname@example.org|
|Contact: PIERRE-YVES ROBERT, Premail@example.com|